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He said doctors were “not sure” about the harms of some devices and the risks could grow as technology was advancing so rapidly.

Boz Michalowska, a medical devices lawyer at the firm Leigh Day, said: “It should be a source of shame for the UK government and its regulatory bodies that patients continue to suffer from such avoidable harm.”

A Department of Health and Social Care spokesperson said the UK regulator, the MHRA, had a “robust process” in place to support the regulation of new medical devices, and it “expected them to follow up any safety concerns swiftly and with patient care in mind”.

“We will work with the regulator to see what future changes may be required,” they said.

The MHRA said the regulatory system for medical devices had been in place for 25 years and medical technology had “improved and transformed countless lives”.

“The need to protect public health, whilst not stifling innovation, must be carefully balanced. The MHRA welcomes innovative medical devices that can bring huge health benefits to people as long as this doesn’t compromise patient safety,” it said.

Maureen ‘the good guinea pig’?

Maureen McCleave, 82 from Essex, was the first person in the UK to be fitted with the “Nanostim” pacemaker because of an irregular heartbeat.

Pacemakers are life-saving implants that deliver electrical pulses to the heart to keep them beating regularly.

How is all this allowed to happen?

Europe does not have a governmental body that checks medical devices before they are put onto the market.

Instead a series of companies called notified bodies issue CE marks – the same mark of approval given to devices like toasters and kettles.

There are 58 of them in Europe and approval by one means a product can be used anywhere in the European Economic Area (the EU plus Iceland, Liechtenstein, and Norway).

But if one body says no, a company can shop around and ask another.

But surely you need evidence?

Less than patients might think.

And there is so much secrecy that even surgeons implanting these devices do not always see the evidence upon which a device has been approved for its safety and effectiveness.

The British Standards Institution said it could not discuss the evidence for Nanostim due to “confidentiality requirements”.

Even the UK’s regulator, the Medicines and Healthcare Products Regulatory Agency, says it is “bound by confidentiality when it comes to some of the actions that we’ve taken around individual devices”.

But the investigation discovered there was only one clinical study before Nanostim was approved for use on the public.

It followed just 33 patients for 90 days.

Image caption Prof Rita Redberg

Prof Rita Redberg, one of the world’s leading cardiologists and from the University of California, San Francisco, said: “We’re talking about a permanently implanted pacemaker, so I think that’s a very tiny study.

“They’re supposed to last 10, 20 years. A 90-day follow up is not enough to learn much about the pacemaker.”

What does the industry say?

MedTech Europe, the body that represents the medical devices industry, said: “Millions of people have safely benefited from medical devices and can now live healthier, more productive and more independent lives.

“Life is unimaginable today without the hundreds of thousands of medical devices in our hospitals and in our homes.”

And it defended the system of notified bodies which were “selected for the expertise, impartiality, transparency and independence of their staff”.

Abbott, which manufactured Nanostim, says that many patients have been helped by leadless pacemakers and many more will benefit from this technology in the future.

It said: “In accordance with the European CE Mark approval process, the Nanostim leadless pacing system was approved based on strong performance and safety data.

“In addition, upon CE Mark approval Nanostim was further assessed through a European post market clinical follow-up study.”

What is the solution?

The UK’s Royal College of Surgeons has called for “drastic regulatory changes”.

Prof Derek Alderson, president of the Royal College of Surgeons, said: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.”

But when the European Union suggested tightening the rules, the industry ran a campaign called “Don’t lose the 3”.

It referred to the fact that manufacturers can get new products to patients three years quicker in Europe then they can in the United States.

New medical device regulation will come into force in Europe in 2020, but campaigners say the new rules do not go far enough.

German MEP Dagmar Roth Behrendt told Panorama that an intensive lobbying campaign by the industry undermined the proposed reforms.

“It’s a success for them and a failure for the European parliament and for European patients, I have no doubt about it.

“It is like an open wound for me, that we could not do more for European patients and for the safety of European patients hurts.”

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